KINEX KA2 Ankle CPM User manual

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1801 Airport Road, Suite D
Waukesha, WI 53188
Phone [phone]/Fax [phone]
KINEX KA2™ ANKLE
Ankle CPM Machine

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Device description
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KINEX-Ankle setup illustrations
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Contents
Description of the KINEX-Ankle System 2
KINEX-Ankle setup illustrations 3
Symbol overview 35
1. How to use the CPM device 5
1.1 Fields of application 5
1.2 Therapy objectives 5
1.3 Indications 5
1.4 Contraindications 5
2. Description of the KINEX-Ankle 6
2.1 Description of the device components 6
2.2 Description of the programming unit 7
2.3 Explanation of symbols 10
2.4 Explanation of symbols (connections and nameplate) 11
3. Safety information 12
4. Device setup 15
4.1 Connecting the device, performance check 15
4.2 Adjusting the device to the patient 16
5. Setting the treatment values 17
5.1 General information on programming KINEX-Ankle 17
5.2 Programming KINEX-Ankle 18
5.3 Treatment value details 19
6. Care, Maintenance, Transport, Conversion 26
6.1 Care 26
6.2 Maintenance (fuse replacement) 26
6.3 Transport 27
6.4 Conversion 28
7. Environmental Protection Statement 29
8. Specifications 29
9. IEC 60601-1-2:2001 30
9.1 Electromagnetic emissions 30
9.2 Electromagnetic immunity 31
9.3 Recommended Separation Distances 33
10. Contact 33
11. Technical service 34
11.1 Technical Hotline 34
11.2 Shipment 34
11.3 Spare Parts 34
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1. How to use the CPM device
The CPM device is indicated in the
treatment of most injuries and diseases
of the ankle joint as well as in the post-
operative treatment after joint surgery
and in the treatment of joint diseases.
Examples:
- joint distortion and contusion
- arthrotomy and arthroscopy procedu-
res in combination with synovectomy,
arthrolysis or other intra-articular in-
terventions
- mobilization of joints in anesthetized
patients
- exercise-stable fractures after sur-
gery, pseudoarthrosis and osteotomy
- myoplasty
- arthroplasties including implantation
of endoprostheses
Do NOT use KINEX-Ankle on
patients with:
- acute inflammatory processes in the
joints, unless on the order of a physi-
cian
- spastic paralysis
- unstable osteosynthesis
1.3 Indications
1.4 Contraindications
KINEX-Ankle is a motor-operated Con-
tinuous Passive Motion (CPM) device
providing motion to the ankle joint.
Suitable for use in hospitals, clinics, ge-
neral practices and rental services, it is
an important supplement to medical
and therapeutic treatment.
CPM therapy with KINEX-Ankle is
mainly used to prevent the negative ef-
fects of immobilization, to allow patients
to regain painless mobility of joints at an
early stage and to promote healing and
achieve a positive functional result.
Other objectives of therapy include:
- improvement of joint metabolism
- prevention of joint stiffness
- promotion of the regeneration and he-
aling of cartilage and damaged liga-
ments
- faster hematoma/fluid resorption
- improved lymph and blood circulation
- thrombosis and embolism prophylaxis
1.1 Fields of application
1.2 Therapy objectives
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2. Description of the KINEX-Ankle
Note: See also page 2!
1. Clamping levers to adjust the height
of the calf support assembly
2. Calf support assembly
3. Motor A (center of rotation for dor-
sal extension/plantar flexion)
4. Bracket for programming unit
5. Clamping lever to adjust the inclina-
tion of the carriage
6. Aiming pin for adjustment of the ro-
tational axis of the upper ankle joint
7. Footplate
8. Knurled screw for adjustment of the
footplate height
9. Knurled screw to adjust the foot-
plate to the leg length
10. Motor B
11. Footplate bracket
12. Thumbscrew to secure motor B on
the moving bracket for dorsal ex-
tension / plantar flexion
13. Bore hole to mount motor B to the
moving bracket for dorsal extension/
plantar flexion
14. CPM base
15. Moving bracket for dorsal extension/
plantar flexion
16. Power switch (ON/OFF)
17. Fuse cap
18. Connection for power cord
19. Locking device to adjust the height
of the carriage
20. Perforation to set the height of the
carriage
21. Programming unit
22. Nameplate
23. Connection for programming unit
2.1 Description of the
device components
The motorized CPM device provides the
following passive motion to the ankle
joint:
plantar flexion / dorsal extension
50° / 0° / 40°
inversion / eversion
40° / 0° / 20°
It can be reconfigured for use on either
side and allows patients to exercise in
bed and while sitting on a chair.
Note!
To unambiguously represent the cur-
rent position of the CPM device, the
values for plantar flexion and inver-
sion are marked with the symbol "-"
both on the display and in this docu-
ment.
These are some of the
KINEX-Ankle features:
- anatomically correct setup
- physiological movements
- programming unit for precise
adjustment of patient-specific
therapy values
- symbols for easy operation of the
programming unit
Biocompatibility
Those parts of the KINEX-Ankle device
that come into contact with the patient
when the device is used as intended,
are designed to fulfil the biocompatibil-
ity requirements of the applicable stan-
dards.
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2.2 Description of the programming unit
2.2.1 Programming unit in normal mode
set angle of motor A
current position of motor A
(arrow pointing up =
dorsal extension
arrow pointing down =
plantar flexion)
set
dorsal extension value
set
plantar flexion value
motor A - selected
direction of motion
set angle of motor B
current position of motor B
(left or right - solid foot
symbol /
arrow pointing inward =
inversion
arrow pointing outward =
eversion)
therapy timer
set eversion value
set inversion value
motor B - selected
direction of motion
parameter keys
MENU key
START key“+” key
“-” key STOPkey
selected therapy
protocol
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2.2.2 Programming unit in MENU selection mode
2.2.3 Programming unit set to ROM programming
set carriage angle for
dorsal extension /
plantar flexion
current position of
motor A
(arrow pointing up =
dorsal extension
arrow pointing down
= plantar flexion)
selected MENU level
selected function
current maximum dorsal
extension value
current maximum plantar
flexion value
set carriage angle
selected parameter
(here: dorsal extension)
set carriage angle for
inversion / eversion
current position of
motor B
(left or right - solid foot
symbol /
arrow pointing inward =
inversion
arrow pointing outward
= eversion)
parameters available for
selection and correspon-
ding parameter keys
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selected function status of the selected
function (here: speed)
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2.2.4 Programming unit in general programming
mode
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2.3 Explanation of symbols
Also refer to symbol overview on page 36
dorsal extension
plantar flexion
inversion
eversion
pause
timer
speed
new patient
load reversal
motor A
load reversal
motor B
motor A ON/OFF
motor B ON/OFF
transport setting
synchronized/non-
synchronized mode
total therapy time
service menu
warm up protocol
isolation protocol
dorsal extension /
plantar flexion therapy
documentation
inversion /
eversion therapy
documentation
stretching in
dorsal extension
stretching in
plantar flexion
stretching in
inversion
stretching in
eversion
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2.4 Explanation of symbols
(connections and nameplate)
alternating current
protective earth
connection
type B applied part
power switch OFF
power switch ON
Refer to accompanying
documents
Do not dispose of
product with unsorted
household or municipal
waste.
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It is mandatory to read the safety state-
ments before use of the CPM device.
The safety statements are classified as
follows:
Danger
This term indicates an imminent haz-
ard. If not avoided, this hazard will
result in death or serious injury.
Warning
This term indicates a hazard. If not
avoided, this hazard can result in
death or serious injury.
Caution
This term indicates a potential haz-
ard. If not avoided, this hazard can
result in minor personal injury and/or
product/property damage.
Definitions
Danger
Explosion hazard –
KINEX-Ankle is not designed for use
in areas where an explosion hazard
may occur. An explosion hazard may
result from the use of flammable
anesthetics, skin cleansing agents
and disinfectants.
Warning
Patient hazard –
- Only authorized individuals are allowed
to operate the KINEX-Ankle de-
vice. Individuals are authorized after
receiving training in the operation of
the device and reading this opera-
tion manual.
- Before using the device, the opera-
tor must ascertain that it is in cor-
rect working order and operating
condition. In particular, the cables
and connectors must be checked
for signs of damage. Damaged
parts must be replaced immedi-
ately, before use.
- Before therapy, a test run consist-
ing of several exercise cycles must
be completed, first without and
then with the patient. Check that all
setting screws are tightened.
- Stop therapy immediately, when
you have doubts about the device
settings and/or the therapy proto-
col.
- It is important that the patient's
position is anatomically correct.
Therefore, carefully verify the fol-
lowing settings/positions:
1. carriage angle
2. ankle joint axis/carriage axis
motor A
3. Footplate adjustment
4. Calf support assembly
Safety information
3. Safety information
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- Movements must not cause any
pain or irritation.
- Patients must be fully conscious
while being instructed in the use of
the CPM device and during therapy.
- The choice of the therapy param-
eters to program and of the ther-
apy protocols to use is restricted
to the responsible physician or
therapist. It is the physician's or
therapist's decision whether or not
to use the CPM device on a spe-
cific patient.
- The patient must be familiar with the
functions of the KINEX-Ankle pro-
gramming unit and the unit must be
within easy reach of the patient,
allowing him or her to stop therapy,
if needed. Patients unable to op-
erate the programming unit, e.g.
paralytic patients, must never be
left unattended during therapy.
- All accessories used with the
KINEX-Ankle device must first be
approved by KINEX.
- Do not allow parts of the body or
any objects (such as blankets, cush -
ions or cables) to get caught in the
moving parts of the CPM device.
Warning
Shock hazard –
Strictly observe the following warn-
ings. Failure to do so endangers the
lives of the patient, the user and
other persons involved.
- Before use allow the KINEX-Ankle
to reach room temperature. If the
device has been transported at
temperatures below 0 °C (32°F),
leave it to dry at room temperature
for about 2 hours, until any conden-
sation has disappeared.
- The KINEX-Ankle device must only
be operated in dry rooms.
- When disconnecting the device
from the power line, remove the
plug from the wall outlet first, be-
fore disconnecting the cable from
the device.
- When connecting the device to
other equipment or when creating a
medical system, check that the sum
of leakage currents will not cause
any hazard. Please contact KINEX,
if you have questions in this matter.
- Do not use multiple portable socket
outlets (MPSO) to connect the de-
vice to the power line. KINEX-Ankle
must be connected to a properly
installed wall outlet with a non-
fused earthed wire. Before con-
necting the power cord, it must be
completely unrolled and placed
such that it will not get caught in
the moving parts of the device.
- Before cleaning and service inter-
ventions, disconnect the device
from the power line by removing the
power cord from the wall outlet.
- Liquids must not be allowed to
enter the CPM device or the pro-
gramming unit. If liquids have en-
tered into the devices, KINEX-Ankle
must be immediately checked by a
service technician, before it can be
reused.
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Warning
Equipment malfunction –
- Magnetic and electrical fields are
capable of interfering with the
proper performance of the device.
For this reason make sure that all
external devices operated in the
vicinity of the CPM device comply
with the relevant EMC require-
ments. X-ray equipment, MRI de-
vices, radio systems and cell
phones are possible sources of in-
terference as they may emit higher
levels of electromagnetic radiation.
Keep the CPM device away from
these devices and verify its per-
formance before use.
- Refer repair and maintenance to
authorized persons.
- Route all cables below the device
frame to either side, ensuring that
they cannot get caught in the mov-
ing parts during operation.
- Inspect KINEX-Ankle for damage
and loose connections at least
once a year. Damaged and worn
parts must immediately be replaced
with original spare parts by author-
ized staff.
Caution
Preventing chafing and pressure
sores – If your patient is adipose,
very tall or very short, be sure to
prevent chafing and pressure sores.
Place the leg concerned in a moder-
ate abductive position, if deemed ap-
propriate.
Caution
Equipment damage –
- Check that the voltage and fre-
quency ratings of your local power
line are those indicated on the
nameplate.
- The leg support element withstands
a maximum continuous load of
20 kg.
- Do not allow any objects (such as
blankets, cushions, or cables) to
get caught in the moving parts of
the CPM device.
- Do not expose the KINEX-Ankle de-
vice to direct sunlight, because
some of the components may reach
inadmissibly high temperatures.
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Note: For a better understanding of
each step, see also pages 2 and 3.
1. Connect the power cord to socket
(18) of the device and connect the
mains plug to a wall outlet with a
non-fused earthed wire (100 to 240
Volt, 50/60 Hz).
2. Turn the power switch (16) on.
Caution
Equipment damage – Be sure to lift
the moving bracket for dorsal
extension / plantar flexion (15) a little,
relieving the strain on it, before you
either press the locking pins for the
height adjustment together or loosen
the clamping lever for adjustment of
the inclination (5).
3. Release the locking device (19). To do
so, first relieve the strain on the car-
riage by lifting the moving bracket for
dorsal extension / plantar flexion (15)
a little. Then press the two black pins
of the locking device together simul-
taneously (Fig. A).
4. Set the carriage to an angle of ap-
prox. 60°, then release the pins of the
locking device. Check that the pins
engage in the perforation (20).
5. Again, hold the moving bracket for
dorsal extension / plantar flexion (15)
and release the clamping lever for ad-
justment of the inclination (5). Then
lower the moving bracket for dorsal
extension / plantar flexion (15) until it
forms an angle of 45° with the base.
Close the clamping lever to lock the
carriage in that position (Fig. B).
4.1 Connecting the
device, performance
check
6. Follow these steps to set the carriage
to the home position
• Press the MENU key on the pro-
gramming unit twice to access pro-
gramming level 2 (with each key
press, you advance one level).
• Press the “new patient”
parameter key and select this
function (a check mark appears in
the circle next to the function).
• Press the START key. The CPM de-
vice automatically enters the home
position.
If the programming unit can be
operated as described above and
KINEX-Ankle enters the home
position (for home position values, refer
to section 5.3), the device has passed
the performance check.
The device also runs performance
checks regularly during operation. This
is what happens, if a problem is identi-
fied:
− An audio signal sounds.
− The device switches off immediately.
− The message "ERR", accompanied
by a code number (e.g. ERR 5),
appears on the display.
In this situation, you may attempt to re-
start the device by turning it briefly off
and on again with the power switch. If
the error message persists, have the de-
vice inspected by a Service technician,
before using it again.
Performance check
4. Device setup
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Before any treatment is possible, adjust
the device as follows:
1. Before you adjust the
KINEX-Ankle to the patient, you may
have to convert the device for use on
the left or right foot (see section 6.4
Conversion).
2. First lift the moving bracket for dorsal
extension / plantar flexion (15) a little
to hold it securely and to remove the
strain. Simultaneously press the two
black pins of the locking device (19)
together. Now you can adjust the
carriage to the correct height.
Release the pins of the locking device
(19). Check that the pins engage in
the perforation (20) (Fig. A).
3. Continue to hold the moving bracket
for dorsal extension / plantar flexion
(15) and release the clamping lever for
adjustment of the inclination (5).
Adjust the correct inclination for the
carriage. Close the clamping lever to
lock the carriage in that position
(Fig. B).
4. Place the patient's leg on the carriage
and adjust the footplate (7) to the
length of the patient's leg. To do so,
loosen the knurled screw (9) and
adjust the footplate accordingly. It is
the purpose of this setting to adjust
the rotational axis of the CPM device
to the compromise center of rotation
of the upper ankle joint. Check that
the foot is firmly positioned against
the footplate. Tighten the knurled
screw (9) (Fig. C).
5. Loosen the clamping lever adjusting
the height of the calf support assem-
bly (1) (Fig. D) and the knurled screw
adjusting the height of the footplate
(8) (Fig. E). Set the calf support
assembly and the footplate to a level
where the rotational axis of the
carriage and the compromise center
of rotation of the upper ankle joint
coincide. Close the clamping lever (1)
and tighten the knurled screw (8)
(Fig. D).
4.2 Adjusting the
device to the
patient
6. Check the settings and make sure
that the patient is comfortably posi-
tioned. If necessary, repeat steps 2
to 5 to achieve a perfect setup.
Note!
- The aiming pin (6) is a valuable aid
in adapting the carriage's rotational
axis to the compromise center of
rotation of the upper ankle joint. It
identifies the correct compromise
axis (Fig. F).
- If the CPM device is to be used on
a supine patient, it is recommended
to select a hip angle of approx. 40°
at the KINEX-Ankle.
Caution
Equipment damage –
- Cover the leg support assemblies
with disposable tissues, when
using the KINEX-Ankle immediately
after surgery. This helps prevent
discoloration.
- Before you change the carriage's
inclination and/or height, always lift
the moving bracket for dorsal ex-
tension / plantar flexion a little.
Caution
Patient hazard –
- Ensure that the rotational axes of
the carriage and of the ankle joint
coincide both in the vertical and in
the horizontal plane (Fig. F).
- Before you change the carriage's
inclination and/or height, always lift
the moving bracket for dorsal ex-
tension / plantar flexion a little.
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Warning
Patient hazard –
Before therapy, a test run consisting
of several exercise cycles must be
completed without the patient. Then
repeat the test run with the patient
and check that the movement does
not cause any pain.
Note!
See also 2.2 and 2.3 as well as page
36!
1. You activate the programming mode
by briefly pressing the MENU key on
the programming unit.
2. The treatment parameters and func-
tions are allocated to six program-
ming levels (four per level).
To be able to program a parameter
you will have to access the corre-
sponding programming level. This is
also done with the MENU key. With
each key press you advance one
level. The code M1, M2, etc. that ap-
pears in the middle of the display in-
dicates the programming level.
3. You activate the treatment parame-
ters and functions with the four pa-
rameter keys below the display. The
symbols above the four parameter
keys indicate the assigned parame-
ters and functions.
5.1 General information
on programming
KINEX-Ankle
This is what happens when you press
one of the parameter keys to select a
parameter:
- The corresponding symbol appears
on the display in a larger format.
- The set value is displayed.
- The symbol above the parameter
key appears in reverse video.
4. With the +/ -keys (plus/minus) you
change the displayed value. When
you press and hold the key, the value
will change at a higher rate.
Some of the (special) functions can
only be enabled and disabled. This is
done by pressing the corresponding
parameter key or with the + / - keys.
Active parameters are identified with
a check mark in the circle next to the
symbol.
5. Having programmed all parameters,
press the STOP key to save the val-
ues.
6. Then press the START key:
KINEX-Ankle will check the set val-
ues, it moves to the middle position
and stops.
7. Press the START key again to start
therapy.
In the synchronized mode, the car-
riage will then move from the middle
position to the maximum eversion
value. Afterwards, the carriage will si-
multaneously move to the maximum
inversion value and to the maximum
plantar flexion value, and then simul-
taneously to the maximum dorsal ex-
tension value and the value halfway
between inversion and eversion. After
reaching this position, the cycle
restarts: maximum eversion at the
same time as halfway between dorsal
extension / plantar flexion, etc.
After activation of the START key in
the non-synchronized mode the mo-
tors will perform random movements,
each motor reversing after reaching
the maximum values.
5. Setting the treatment values
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To program the different settings of the
KINEX-Ankle Standard, access the re-
spective programming level.
You change between levels by pressing
the MENU key.
The display always indicates the cur-
rently selected level.
The following treatment values,
settings and information can be en-
tered/viewed on the programming unit
(21):
Note!
- Refer to sections 5.3 for a descrip-
tion of the parameters.
- To view the set parameter values,
press the corresponding parameter
key. Before, however, you have to
press the STOP key and access the
correct menu level.
- To prevent accidental changes of
the parameter settings, lock the
keys by simultaneously pressing
the + (plus) and – (minus) keys.
- Press both keys again to unlock.
- Emergency stop function:
KINEX-Ankle will stop immediately,
when any of the keys is pressed
during therapy. When the START
key is pressed in the
synchronized mode, the carriage
will move to the position halfway
between the set values, and stops.
Patient treatment can be resumed
by pressing the START key. When
the START key is pressed again in
the non-synchronized mode, the
carriage will reverse its direction.
5.2 Programming
KINEX-Ankle
18
LEVEL 1:
- dorsal extension
- plantar flexion
- inversion
- eversion
LEVEL 2:
- pause
- therapy timer
- speed
- new patient
LEVEL 3:
- reverse on load - motor A
- reverse on load - motor B
- motor A ON/OFF
- motor B ON/OFF
LEVEL 4:
- warm-up protocol
- isolation program
- therapy documentation
dorsal extension /
plantar flexion
- therapy documentation
inversion / eversion
LEVEL 5:
- stretching in dorsal extension
- stretching in plantar flexion
- stretching in inversion
- stretching in eversion
MENU
MENU
MENU
MENU
MENU
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LEVEL 6:
- transport setting
- synchronized/
non-synchronized mode
- total therapy time
- service menu
- To access the programming level you
need, press the MENU key repeatedly.
- The treatment parameters are selected
with the different parameter keys.
- To change the treatment values, press
the + / – keys.
- To enable/disable a function, press the
respective parameter key again.
- To save the entered values, press the
STOP key.
With the default settings all special
functions are disabled.
■dorsal extension
maximum value: 40 degrees
■plantar flexion
maximumvalue: - 50 degrees
LEVEL 1
5.3 Treatment value
details
Note!
- While you adjust the
extension/flexion values, the car-
riage will not move to the set range.
Take care that the patients ankle is
able to move in the set ROM.
- The angle entered last for the re-
spective directions of motion will be
saved in each case.
■inversion
maximum value: - 40 degrees
■eversion
maximum value: 20 degrees
■pauses
Pauses occur at each programmed
maximum value.
These are the three pause points:
maximum dorsal value at the same
time as halfway between inversion /
eversion
maximum eversion value at the same
time as halfway between dorsal ex-
tension / plantar flexion
maximum plantar flexion at the same
time as maximum inversion
Pauses can be set to any value be-
tween 0 and 59 seconds in steps of 1
second, and to values between 1 and
59 minutes in steps of 1 minute.
default setting: no pause
LEVEL 2
Note!
- The programmed values and the
values measured at the patient's
foot may deviate slightly.
- When the START key is pressed in
the synchronized mode, the device
will first move from the middle posi-
tion to the maximum eversion value.
Afterwards, the carriage will simul-
taneously move to the maximum
inversion value and to the maximum
plantar flexion value, and then si-
multaneously to the maximum dor-
sal extension value and to the value
halfway between inversion and
eversion. After reaching this posi-
tion, the cycle restarts: maximum
eversion at the same time as
halfway between dorsal extension /
plantar flexion, etc.
19
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■therapy timer
Default setting is continuous
operation.
A clock symbol in the upper right-
hand corner of the display identifies
the continuous mode of operation.
The clock indicates the elapsed ther-
apy time.
In the continuous mode, the device
must be stopped with the STOP key.
However, you can also select therapy
durations of 1 to 59 minutes in steps
of 1 minute and of 1 to 24 hours in
steps of 30 minutes.
When the time has elapsed, the de-
vice switches automatically off and
stops in the middle between the set
limit values.
In this case, a circle replaces the
clock symbol. The circle fills as the
therapy time progresses.
■speed
The speed can be adjusted between
5 % and 100 % in steps of 5 %.
default setting: 50 %
■new patient
With this function, the CPM device
will move to the home position. Select
the function and press the START
key. The device enters the home posi-
tion and existing therapy parameters
will be deleted.
The carriage stops in the home posi-
tion, dorsal extension / plantar flexion
= 0° and inversion / eversion = 5°.
The "new patient" function (home po-
sition) selects the following settings:
- dorsal extension: 20°
- plantar flexion: - 20°
- inversion: - 5 °
- eversion: 15°
- pauses: 0
- timer: continuous
operation
- speed: 50 %
- reverse on load -
motor A: 25
- reverse on load -
motor B: 25
- motor A: ON
- motor B: ON
- synchronized mode: enabled
- total therapy time: 0
- special functions: disabled
■reverse on load - motor A
(safety circuit)
In the synchronized mode, the
carriage automatically moves to the
middle position when the patient's re-
sistance (load) exceeds the set value.
In the non-synchronized mode, the
carriage automatically moves in the
opposite direction when the patient's
resistance (load) exceeds the set
value.
Adjustable levels for reverse on load
feature: 1 - 25 at level 1, very little re-
sistance will cause the device to re-
verse; at level 25, a high resistance is
required to initiate the reversal.
default setting: level 25
■reverse on load - motor B
(safety circuit)
In the synchronized mode, the
carriage automatically moves to the
middle position when the patient's re-
sistance (load) exceeds the set value.
In the non-synchronized mode, the
carriage automatically moves in the
opposite direction when the patient's
resistance (load) exceeds the set
value.
Adjustable levels for reverse on load
feature: 1 - 25 at level 1, very little re-
sistance will cause the device to re-
verse; at level 25, a high resistance is
LEVEL 3
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KINEX-Ankle Gebr DV2 706 16.07.2007 14:03 Uhr Seite 20